Phoenix Atherectomy System
Product: Phoenix 2.2mm x 130cm 6F Pre-Deflected Atherectomy System — all models and sizes
FDA Clearance Information
The Phoenix Atherectomy System was cleared by the FDA via the 510(k) pathway on December 20, 2018. It is manufactured by Volcano Atheromed and classified as a Class 2 device.
What It Is
FDA-Cleared Indications
- Treatment of peripheral arterial disease in peripheral arteries.
- Removal of atherosclerotic plaque and other obstructive material from diseased peripheral arteries.
- Use during endovascular treatment of lesions when plaque debulking is clinically indicated.
Clinical Applications
- Atherectomy of stenotic or occluded peripheral arterial lesions.
- Plaque debulking before or during balloon angioplasty.
- Treatment of complex or heavily calcified lesions in peripheral arteries when the device's labeled vessel-size and access requirements are met.
- Endovascular treatment of femoropopliteal peripheral artery disease.
Reported off-label uses
- Use in infrapopliteal or below-the-knee lesions may be reported in clinical practice, but the specific vessel and lesion indications must be confirmed in the current device labeling.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
Reported Outcomes
Safety Profile
Evidence Limitations
Practical Considerations
- The system is delivered through a vascular access sheath or catheter and requires fluoroscopic imaging; exact compatible sheath, guidewire, catheter, and vessel-size requirements depend on the device model and current instructions for use.
- Access is commonly obtained through the common femoral artery, with treatment directed to the femoropopliteal or other labeled peripheral arterial segment.
- Atherectomy may be followed by balloon angioplasty, stenting, or other therapy based on residual stenosis, dissection, embolization risk, and blood flow.
- Potential complications include bleeding or hematoma at the access site, arterial perforation or dissection, distal embolization, thrombosis, vessel spasm, infection, and contrast-related complications.
- MRI safety is model- and labeling-dependent. The current device instructions should be reviewed before MRI; a removed catheter is generally not an MRI concern, while any retained component requires specific evaluation.
Linked Studies (8)
Multicenter comparison of Etest, Vitek2 and BD Phoenix to broth microdilution for beta-lactam susceptibility testing of Streptococcus pneumonia.
European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology
RCT|prospective|retrospective|case Series|other View Source →Safety and effectiveness of the Phoenix atherectomy device for endovascular treatment of common femoral and popliteal arteries: Results of the EN-MOBILE trial.
Vascular medicine (London, England)
View Source →Crossing complex infrapopliteal lesions utilizing a front-end cutting technique: A report of two cases with a novel rotational atherectomy device.
SAGE open medical case reports
View Source →Acute Real-World Outcomes From the Phoenix Post-Approval Registry.
The Journal of invasive cardiology
Other View Source →Phoenix atherectomy for patients with peripheral artery disease.
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
RCT|prospective|retrospective|case Series|other View Source →A Single-Center Experience With Phoenix Atherectomy System in Patients With Moderate to Heavily Calcified Femoropopliteal Lesions.
Cardiovascular revascularization medicine : including molecular interventions
RCT|prospective|retrospective|case Series|other View Source →Hybrid atherectomy for lower extremity peripheral arterial disease.
Vascular
RCT|prospective|retrospective|case Series|other View Source →Safety and effectiveness of the Phoenix Atherectomy System in lower extremity arteries: Early and midterm outcomes from the prospective multicenter EASE study.
Vascular
View Source →Frequently Asked Questions
What are the clinical indications for Phoenix Atherectomy System?
The Phoenix Atherectomy System is indicated for the treatment of peripheral artery disease, particularly in patients with complex, calcified lesions in the femoropopliteal and infrapopliteal arteries.
What outcomes have been reported in clinical studies?
Clinical studies have reported that the Phoenix Atherectomy System effectively debulks complex lesions, improves blood flow, and reduces stenosis in treated vessels.
What complications have been reported?
Reported complications include procedural risks such as vessel perforation and embolization, although the device generally has a favorable safety profile.